The U.S. Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CEBR) released their draft guidance for industry on evaluating donor eligibility by risk-based questions to reduce the risk of HIV transmission by blood and blood products.

The draft guidance recommends a change in the donor history questionnaire (DHQ) to assess individual risk for HIV, including history of a positive test, taking medication for HIV, HIV prophylaxis use, history of sexual behaviors and drug use, and history of contact with another person’s blood, tattoo or piercing, and any sexual transmitted diseases.

The updated deferral guidance does not recommend deferral for men who have sex with men (MSM), but rather for any person who has had a new sexual partner or more than one sexual partner in the past 3 months and engaged in anal sex during that time. A 3-month deferral was also recommended from the last dose of short-acting pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) and 2 years from the most recent injection of long-acting PrEP.

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Individuals who received a tattoo should be deferred for 3 months unless the tattoo was performed by a state-regulated entity that used sterile needles and non-reused ink. Similarly, individuals who received a piercing with single-use equipment do not need to undergo the 3-month deferral period.

This updated guidance is a result of a series of events that generated modern data about the risk of HIV in donated blood from groups at-risk of HIV. This included data from the Transfusion Transmissible Infections Monitoring System (TTIMS) and ADVANCE study, data collected after the deferral period for at-risk groups was changed to 3 months in 2020, and data from other countries with similar HIV incidence who updated their deferral recommendations.

The FDA will consider comments submitted to within 60 days for the final draft of the guidance.


Center for Biologics Evaluation and Research. Recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of human immunodeficiency virus transmission by blood and blood products. Draft Guidance for Industry. Docket number: FDA-2015-D-1211. Published January 2023. Accessed February 2, 2023.